CONNECTOR 811206GR 50MM TI 5.5MM ROD S
CD HORIZON® Growth Rod Conversion Set - 811206GR
Device Description
An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.
Environmental Conditions
No Data Available
Device Sizes
- DIA=5.5mm L=50mm
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PGM
Device Name: Growing Rod System
Device Class: 2
Physical State: Metalllic rods, monoaxial or polyaxial bone screws, hooks, and other related accessories.
Definition: Stabilization or correction of spinal deformities without the use of fusion.
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: The system of distracting or compressing rods and fixation elements (screws, hooks, etc.) provides stabilization and correction of the spine as the child grows.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: Pediatric spine.
Regulation Number: 888.3070
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 00643169500426
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A